The dangers of conventional medicine .Why alternative medicine grows

http://www.nytimes.com/2007/12/12/bu...&oref=slogi n

Another Study Finds Heart Risks in a Diabetes Drug

An independent analysis of thousands of older people with diabetes
found that those treated with the widely used drug Avandia had
significantly elevated risks of heart attack and death. .......

..........The new study concludes that Avandia users had a 60
percent increased risk of heart failure, a 40 percent increased risk
of heart attacks and a 30 percent increased risk of death compared
with patients taking other oral diabetes medicines. ....


Thanks Vince

"bigvince" wrote in message
...
http://www.nytimes.com/2007/12/12/bu...&oref=slogi n

Another Study Finds Heart Risks in a Diabetes Drug

An independent analysis of thousands of older people with diabetes
found that those treated with the widely used drug Avandia had
significantly elevated risks of heart attack and death. .......

..........The new study concludes that Avandia users had a 60
percent increased risk of heart failure, a 40 percent increased risk
of heart attacks and a 30 percent increased risk of death compared
with patients taking other oral diabetes medicines. ....


Thanks Vince

Vince, why didn't you play a Mark Thorson? Making the title Drugs KILL!!!
Just kidding.

FDA: the data are inconclusive and we have added a boxed warning to the
labeling.

http://www.commondreams.org/news2007/0525-05.htm

Scientists, Public Health Advocates and Consumer Groups Demand Impartial FDA
Review of Commonly Used Diabetes Drug
Recent Study Finds Avandia Increases Risk of Heart Attack, Death

WASHINGTON - MAY 25 - A coalition of scientific, public health and consumer
organizations today issued a letter urging the Food and Drug Administration
(FDA) to exclude scientists with financial ties to GlaxoSmithKline from a
panel reviewing the safety of the pharmaceutical giant's popular type 2
diabetes drug, Avandia.


Earlier this week the FDA announced it would form the advisory panel in
response to a New England Journal of Medicine article that found Avandia
increases the risk of heart attacks by 43 percent and the risk of heart
death by 64 percent.

"The Avandia controversy raises once again the memory of Vioxx, which was
approved by the FDA and then withdrawn from the market after tens of
thousands of people died," said Francesca Grifo, director of the Scientific
Integrity Program at the Union of Concerned Scientists, a coalition member.
"The FDA must demonstrate that it is serious about drug safety and making
sure its outside experts are impartial."

The FDA also issued a public safety alert this week advising users of the
drug to consult with their doctors about potential cardiovascular risks. The
FDA disclosed it had known about the Avandia's potential risk since August
2006.

There is currently no law requiring the FDA to appoint members with no
conflicts of interest to its scientific advisory panels. On May 9, the
Senate defeated an amendment to an FDA reform bill that would have
restricted the agency's use of experts with financial ties to drug makers.

Joining the Union of Concerned Scientists on the letter, which was delivered
today to FDA Commissioner Andrew von Eschenbach, were the Center for Medical
Consumers, Center for Science in the Public Interest, Consumers Union,
Government Accountability Project, National Research Center for Women &
Families, National Women's Health Network, U.S. PIRG and WoodyMatters. The
letter is attached below.

###

The Union of Concerned Scientists is the leading science-based nonprofit
organization working for a healthy environment and a safer world. Founded in
1969, UCS is headquartered in Cambridge, Massachusetts, and has offices in
Berkeley, California, and Washington, D.C. For more information, go to
www.ucsusa.org.

###

May 24, 2007

Dr. Andrew C. von Eschenbach
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20856

Dear Dr. von Eschenbach,

The American public is once again dismayed to discover that the Food and
Drug Administration (FDA) has approved a drug whose risks may vastly
outweigh its benefits. A study released Monday, May 21 in the New England
Journal of Medicine indicates that Avandia may significantly increase the
risk of heart attacks. Since diabetics are already at high risk of
cardiovascular events as a result of their disease, the possibility of a
drug-related increased risk of heart attack calls into question the wisdom
of the continued use of this drug, as well as the basis on which it was
approved.

In light of this study, and faltering public faith in the integrity of the
FDA drug approval process, we write to urge you to ensure that the
composition of any advisory committee that is being convened to review the
safety of Avandia be free of any conflict of interest. At the minimum, no
member of this committee should have had any financial ties to
GlaxoSmithKline, Avandia's maker, for the past 36 months.

No law currently mandates that the FDA use only non-conflicted scientists on
its advisory committees. But history teaches us that when scientists have
conflicts of interest, the well being of the public may be compromised. Last
December, a company-funded study of Avandia showed no increased heart attack
risk when comparing rosiglitazone (Avandia) to metformin, a commonly
prescribed generic drug widely used for glycemic control. Every author of
that study either worked for or had financial ties to GlaxoSmithKline.

In February 2005, ten of the 32 scientists on the advisory committee that
considered the safety of Cox-2 inhibitors, including Vioxx, had ties to the
drug companies that made the products. The scientists voted to permit the
companies to continue marketing the drugs, even though Vioxx had already
been withdrawn from the market and had been implicated in tens of thousands
of deaths.

By staffing the Avandia advisory committee with scientists from diverse
specialties who are non-conflicted, you will send a message that the FDA
cares about avoiding conflicts of interest and evaluating drugs on the basis
of unbiased scientific findings.

The Avandia panel is just a first step in restoring public confidence. We
urge you to take all steps necessary, including an expanded outreach to
Schools of Public Health, to ensure that all future FDA advisory committees
include only non-conflicted voting members, and to drastically curb the use
of waivers to permit members with conflicts to participate on these
committees.

Very truly yours,

Paul Brown Consumer
Health Care Advocate U.S. PIRG

Mark P. Cohen
Food and Drug Safety Director Government Accountability Project

Merrill Goozner
Director, Integrity in Science Center for Science in the Public Interest

Francesca T. Grifo, Ph.D.
Scientific Integrity Program Director Union of Concerned Scientists

Arthur Aaron Levin, MPH
Center for Medical Consumers

Cindy Pearson
Executive Director National Women's Health Network

Bill Vaughan
Consumers Union

Kim Witczak
WoodyMatters

Diana Zuckerman, Ph.D.
President National Research Center for Women & Families

cc. vSteven Galson, M.D., M.Ph.
Director, Center for Drug Evaluation and Research

Robert Meyer, M.D.
Director, Office of Drug Evaluation II

Looks like GlaxoSmithKline is now in trouble with Avandia...

Another Vioxx!

A coalition of scientific, public health and consumer organizations today
issued a letter urging the Food and Drug Administration (FDA) to exclude
scientists with financial ties to GlaxoSmithKline from a panel reviewing
the safety of the pharmaceutical giant's popular type 2 diabetes drug,
Avandia.

This is "evidence based medicine" for you... Conflicts of interest are the
rule!



Science for sale...


Yuri.

"Jan Drew" wrote in message
news

"bigvince" wrote in message
...
http://www.nytimes.com/2007/12/12/bu...&oref=slogi n

Another Study Finds Heart Risks in a Diabetes Drug

An independent analysis of thousands of older people with diabetes
found that those treated with the widely used drug Avandia had
significantly elevated risks of heart attack and death. .......

..........The new study concludes that Avandia users had a 60
percent increased risk of heart failure, a 40 percent increased risk
of heart attacks and a 30 percent increased risk of death compared
with patients taking other oral diabetes medicines. ....


Thanks Vince

Vince, why didn't you play a Mark Thorson? Making the title Drugs KILL!!!
Just kidding.

FDA: the data are inconclusive and we have added a boxed warning to the
labeling.

http://www.commondreams.org/news2007/0525-05.htm

Scientists, Public Health Advocates and Consumer Groups Demand Impartial
FDA Review of Commonly Used Diabetes Drug
Recent Study Finds Avandia Increases Risk of Heart Attack, Death

WASHINGTON - MAY 25 - A coalition of scientific, public health and
consumer organizations today issued a letter urging the Food and Drug
Administration (FDA) to exclude scientists with financial ties to
GlaxoSmithKline from a panel reviewing the safety of the pharmaceutical
giant's popular type 2 diabetes drug, Avandia.


Earlier this week the FDA announced it would form the advisory panel in
response to a New England Journal of Medicine article that found Avandia
increases the risk of heart attacks by 43 percent and the risk of heart
death by 64 percent.

"The Avandia controversy raises once again the memory of Vioxx, which was
approved by the FDA and then withdrawn from the market after tens of
thousands of people died," said Francesca Grifo, director of the
Scientific Integrity Program at the Union of Concerned Scientists, a
coalition member. "The FDA must demonstrate that it is serious about drug
safety and making sure its outside experts are impartial."

The FDA also issued a public safety alert this week advising users of the
drug to consult with their doctors about potential cardiovascular risks.
The FDA disclosed it had known about the Avandia's potential risk since
August 2006.

There is currently no law requiring the FDA to appoint members with no
conflicts of interest to its scientific advisory panels. On May 9, the
Senate defeated an amendment to an FDA reform bill that would have
restricted the agency's use of experts with financial ties to drug makers.

Joining the Union of Concerned Scientists on the letter, which was
delivered today to FDA Commissioner Andrew von Eschenbach, were the Center
for Medical Consumers, Center for Science in the Public Interest,
Consumers Union, Government Accountability Project, National Research
Center for Women & Families, National Women's Health Network, U.S. PIRG
and WoodyMatters. The letter is attached below.

###

The Union of Concerned Scientists is the leading science-based nonprofit
organization working for a healthy environment and a safer world. Founded
in 1969, UCS is headquartered in Cambridge, Massachusetts, and has offices
in Berkeley, California, and Washington, D.C. For more information, go to
www.ucsusa.org.

###

May 24, 2007

Dr. Andrew C. von Eschenbach
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20856

Dear Dr. von Eschenbach,

The American public is once again dismayed to discover that the Food and
Drug Administration (FDA) has approved a drug whose risks may vastly
outweigh its benefits. A study released Monday, May 21 in the New England
Journal of Medicine indicates that Avandia may significantly increase the
risk of heart attacks. Since diabetics are already at high risk of
cardiovascular events as a result of their disease, the possibility of a
drug-related increased risk of heart attack calls into question the wisdom
of the continued use of this drug, as well as the basis on which it was
approved.

In light of this study, and faltering public faith in the integrity of the
FDA drug approval process, we write to urge you to ensure that the
composition of any advisory committee that is being convened to review the
safety of Avandia be free of any conflict of interest. At the minimum, no
member of this committee should have had any financial ties to
GlaxoSmithKline, Avandia's maker, for the past 36 months.

No law currently mandates that the FDA use only non-conflicted scientists
on its advisory committees. But history teaches us that when scientists
have conflicts of interest, the well being of the public may be
compromised. Last December, a company-funded study of Avandia showed no
increased heart attack risk when comparing rosiglitazone (Avandia) to
metformin, a commonly prescribed generic drug widely used for glycemic
control. Every author of that study either worked for or had financial
ties to GlaxoSmithKline.

In February 2005, ten of the 32 scientists on the advisory committee that
considered the safety of Cox-2 inhibitors, including Vioxx, had ties to
the drug companies that made the products. The scientists voted to permit
the companies to continue marketing the drugs, even though Vioxx had
already been withdrawn from the market and had been implicated in tens of
thousands of deaths.

By staffing the Avandia advisory committee with scientists from diverse
specialties who are non-conflicted, you will send a message that the FDA
cares about avoiding conflicts of interest and evaluating drugs on the
basis of unbiased scientific findings.

The Avandia panel is just a first step in restoring public confidence. We
urge you to take all steps necessary, including an expanded outreach to
Schools of Public Health, to ensure that all future FDA advisory
committees include only non-conflicted voting members, and to drastically
curb the use of waivers to permit members with conflicts to participate on
these committees.

Very truly yours,

Paul Brown Consumer
Health Care Advocate U.S. PIRG

Mark P. Cohen
Food and Drug Safety Director Government Accountability Project

Merrill Goozner
Director, Integrity in Science Center for Science in the Public Interest

Francesca T. Grifo, Ph.D.
Scientific Integrity Program Director Union of Concerned Scientists

Arthur Aaron Levin, MPH
Center for Medical Consumers

Cindy Pearson
Executive Director National Women's Health Network

Bill Vaughan
Consumers Union

Kim Witczak
WoodyMatters

Diana Zuckerman, Ph.D.
President National Research Center for Women & Families

cc. vSteven Galson, M.D., M.Ph.
Director, Center for Drug Evaluation and Research

Robert Meyer, M.D.
Director, Office of Drug Evaluation II